Coated Devices to Decrease Infection in the Intensive Care Unit (CRITIC)

Randomized Controlled Open-label Trial Assessing the Efficacy of a Bundle of Coated Devices to Reduce Nosocomial Infections in the Intensive Care Unit

Pilot explanatory, randomized, open label, controlled trial. Critically ill patients which will demand placement of invasive devices for organ support (endotracheal tube, central venous catheter and urinary Foley catheter) will be randomized 1:1 to receive coated (Bactiguard®) or habitual (non-coated) devices.

Study Overview

• Status: Completed
• Conditions: Critically Ill
• Intervention / Treatment: Device: Coated devices; Device: Control

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • Hospital Paulistano
  • São Paulo, Brazil
    • Hospital da Luz
  • São Paulo, Brazil
    • Hospital Sao Paulo - UNIFESP
  • São Paulo, Brazil
    • AC Camargo Câncer Center
  • SP
    • São Paulo, SP, Brazil, 04005000
      • Hospital do Coracao
  • São Paulo
    • Rio Preto, São Paulo, Brazil
      • Hospital de Base de Sao Jose do Rio Preto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients admitted to the intensive care unit which will require simultaneous insertion of all three devices (endotracheal tube, central venous catheter and urinary catheter) due to illness severity as defined by the attending physician.

Exclusion Criteria:

• Patients admitted to the intensive care unit for more than 48 hours or admitted in the hospital for more than seven days
• Presence of any of the invasive devices (endotracheal tube, central venous catheter or urinary catheters) before randomization and absence of the intention to exchange the devices;
• Previous use of any type of coated devices;
• Age < 18 years;
• Known pregnancy
• Known allergy to gold, silver and palladium;
• Suspected or confirmed brain death;
• Previously enrolled in the study

Newly added exclusion criteria in version 2.0:

• Severe chronic pulmonary obstructive disease which may limit catheter site selection
• Previous irradiation and/or thrombosis in site selected for catheter insertion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Bactiguard-coated Devices; Patients will receive endotracheal tube, central venous catheter and urinary cather coated with gold, silver and palladium (Bactiguard coating)	Device: Coated devices; Gold-silver-palladium coated devices (endotracheal tube, central venous catheter and urinary catheter) will be used whenever necessary. All three devices are required to be inserted as soon as possible after randomization and need for all three devices are the main inclusion criteria
PLACEBO_COMPARATOR: Control; Shelf endotracheal tube, central venous catheter and urinary cather available at each intensive care unit without any type of coating designed to prevent infection	Device: Control; Devices without coating available at each participating intensive care unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants recruited in each center during the trial	Assess the recruitment rate	Through study completion, an average of 1 year
Number of participants admitted to the intensive care unit that requires simultaneous insertion of endotracheal tube, central venous catheter and urinary catheter	Assess how many patients admitted to the intensive care unit will demand insertion of endotracheal tube, urinary catheter and central venous catheter after admission in all patients	Through study completion, an average of 1 year
Feasibility - Occurence of sepsis	Occurrence of sepsis after admission in patients that require all three devices to be inserted in all patients	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sepsis	Occurrence of sepsis after randomization (defined as infection plus organ failure)	28 days
Occurence of ventilator-associated pneumonia	Occurence of ventilator-associated pneumonia by radiographic and clinical criteria	28 days
Occurence of central venous catheter-related bloodstream infection	Occurence of central venous catheter-related bloodstream infection using Brazilian regulatory agency criteria	28 days
Occurence of urinary catheter-related infection	Occurence of urinary catheter-related infection defined as positive urinary culture coupled with fever and without any other infection source	28 days
Rate of composite endpoint of ventilator-associated pneumonia and/or central venous catheter-related bloodstream infection and/or urinary catheter-related infection	Occurrence of any of the infections above	28 days
Antibiotic-free days	Number of days not receiving antibiotics	28 days
Number of patients that die in Intensive Care Unit	Mortality during intensive care unit stay	Through intensive care unit stay, an average of 28 days
Number of patients that die during hospital stay	Mortality during hospital stay	Through hospital stay, an average of 40 days

Collaborators and Investigators

• Sponsor: Hospital do Coracao
• Collaborators: Bactiguard AB
• Investigators: Study Director: Alexandre Biasi, MD/PhD, Hospital do Coracao

Publications and helpful links

General Publications

• Zampieri FG, de Oliveira NE, Nassar AP Jr, de Oliveira Manoel AL, Grion C, Lacerda FH, Maia I, Thompson M, Giancursi TS, de Aquino Martins P, Lisboa T, Abait T, Damiani LP, Machado FR, Cavalcanti AB; BRICNet. Bundle of Coated Devices to Reduce Nosocomial Infections in the Intensive Care Unit. CRITIC Pilot Randomized Controlled Trial. Ann Am Thorac Soc. 2020 Oct;17(10):1257-1263. doi: 10.1513/AnnalsATS.202003-206OC.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 6, 2019
• Primary Completion (ACTUAL): February 13, 2020
• Study Completion (ACTUAL): February 28, 2020

Study Registration Dates

• First Submitted: March 6, 2019
• First Submitted That Met QC Criteria: March 7, 2019
• First Posted (ACTUAL): March 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 9, 2020
• Last Update Submitted That Met QC Criteria: March 6, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: sepsis; ventilator-associated pneumonia; catheter related bloodstream infection; urinary catheter-related infection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Critical Illness
• Other Study ID Numbers: CRITIC_PILOT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No